← Product Code [BZL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL) · K110810 # ANASCIENT BREATH MONITOR (K110810) _Invoy Technologies, LLC · BZL · Jun 21, 2011 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K110810 ## Device Facts - **Applicant:** Invoy Technologies, LLC - **Product Code:** [BZL](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL.md) - **Decision Date:** Jun 21, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1730 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** 3rd-Party Reviewed ## Indications for Use The Anascient™ Breath Monitor is intended for use in clinical and research applications to measure oxygen uptake. ## Device Story Anascient™ Breath Monitor measures oxygen uptake for clinical and research applications. Device captures breath samples; analyzes gas composition to determine oxygen consumption rates. Used in clinical settings by healthcare professionals to assess metabolic status. Output provides quantitative data on oxygen uptake, assisting clinicians in evaluating patient metabolic function and guiding therapeutic decisions. ## Clinical Evidence No clinical data provided; substantial equivalence determination based on technological characteristics and intended use. ## Technological Characteristics Oxygen uptake computer; class II device (21 CFR 868.1730); product code BZL. Measures gas exchange parameters for metabolic assessment. ## Regulatory Identification An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Intertek Testing Services C/O Mr. Bhavesh V. Sheth Responsible Third Party Official Invoy Technologies, LLC 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087 JUN 2 1 2011 Re: K110810 Trade/Device Name: Anascient™ Breath Monitor Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: II Product Code: BZL Dated: June 3, 2011 Received: June 6, 2011 Dear Mr. Sheth: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2- Mr. Sheth Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Wh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Invoy Technologies LLC. The logo features a stylized letter "i" to the left of the company name. The text "INVOY TECHNOLOGIES LLC" is written in a bold, sans-serif font. ## Indications for Use Anascient™ Breath Monitor Device Name: ## Indications for Use: The Anascient™ Breath Monitor is intended for use in clinical and research applications to measure oxygen uptake. Prescription Use _XXX (21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L. Schulte (Division Sign-Off) r vision of Anesthesiology, General Hospital fection Control, Dental Devices 10(k) Number: k 110810 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K110810](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K110810) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com